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Study of Offspring of Women With Type 1 Diabetes (EPICOM)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Copenhagen
Department of Gynaecology and Obstetrics, Rigshospitalet, Copenhagen
Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark
University of Southern Denmark
University of Aarhus
Aarhus University Hospital
Information provided by (Responsible Party):
Zuzana Vlachová, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01559181
First received: March 19, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

There is an increasing trend in the society for developing obesity, type 2 diabetes and cardiovascular diseases. It is therefore important to identify the risk factors behind this tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy (as in mothers with type 1 diabetes) may play a role in the development of obesity, type 2 diabetes and cardiovascular diseases later in life for the children. Some studies suggest that high blood sugar levels during pregnancy can also affects cognitive function as well as growth and development of puberty. The mechanisms behind this are not sufficiently clarified yet.

In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and information about the course of pregnancy was collected, including the long-term blood sugar level during pregnancy and the children's' condition at birth. The unique opportunities in Denmark to identify and follow the children of these mothers and the possibility to select a comparison group of children of non-diabetic mothers gives a unique opportunity to examine the children of mothers with type 1 diabetes and accurately investigate the effect of blood sugar levels in pregnancy on conditions later in life.

There has not previously been made any study of this size and it is the investigators hope to be able to quantify the effect of blood sugar level during pregnancy on outcomes later in life. This will potentially give the possibility to detect individuals at risk for cardiovascular diseases earlier and to improve prevention targets in children of mothers with diabetes.


Condition
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Environmental Versus Genetic and Epigenetic Influences on Growth, Metabolism and Cognitive Function in Offspring of Mothers With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Overweight [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
    Weight (> 85-percentile for age and gender)

  • Diabetes/prediabetes [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
    Assessed by Oral Glucose Tolerance Test

  • Cognitive functions [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
    Assessed by RIAS-test and Conners' CPT II.

  • Pubertal development [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
    % body fat assessed by DEXA scannin

  • Blood pressure [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
  • Dyslipidemia [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
  • Markers of endothelial function [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
  • Markers of autoimmunity [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]
    GAD-antibodies

  • PCOS [ Time Frame: 0 - 18 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum and plasma. Tissue biopsies from m. vastus lateralis and subcutaneous abdominal fat (only selected subgroup of participants)


Estimated Enrollment: 900
Study Start Date: April 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposure to intrauterine hyperglycemia
The study group includes the offspring of women with type 1 diabetes from the national diabetes birth registry (1993-99, n=900) with information of HbA1c prior to conception and/or 1st trimester HbA1c.
Control group
The control group including offspring of women without diabetes who delivered during the same period matched with respect to gender and age of offspring and the family's postcode as an indirect marker of the socioeconomic background.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Offspring of mothers with type one diabetes.

Criteria

Inclusion Criteria:

  • Children (diabetes exposed) from the national diabetes birth registry born between 1993 and 1999 (approximately n = 450) The same number of controls from the Central Person Register matched according to gender, age and postcode.

Exclusion Criteria:

  • Offspring with major handicaps or chronic disease will be registered, but will not be examined.
  • Multiple pregnancies and recurrent pregnancies will not be included in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559181

Locations
Denmark
Aarhus Universitetshospital
Aarhus, Denmark, 8000
Department of Gynaecology and Obstetrics, Rigshospitalet
Copenhagen, Denmark, 2100
Odense University Hospital, Diabetes Research Center
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Department of Gynaecology and Obstetrics, Rigshospitalet, Copenhagen
Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark
University of Southern Denmark
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Dorte Møller Jensen, Associated Professor, PhD Odense University Hospital
  More Information

No publications provided

Responsible Party: Zuzana Vlachová, MD, Cand. med., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01559181     History of Changes
Other Study ID Numbers: 2011-41-6044
Study First Received: March 19, 2012
Last Updated: May 6, 2013
Health Authority: Denmark: Danish Data Protection Agency
Denmark: The Ethics Committee of the Regions of Central Denmark

Keywords provided by Odense University Hospital:
Offspring of mothers with type 1 diabetes
Pregnancy and programing
Intrauterine hyperglycaemia
Study focuses on offspring of mothers with type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013